Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can
cause injury to the heart, and this is one of the main reasons it cannot be administered as
planned. Heart injury can often be successfully treated using cardiac medications. The
objectives of SCHOLAR-2 are to evaluate whether is it safe and effective to continue
trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2
positive breast cancer despite mild, minimally symptomatic or asymptomatic systolic left
ventricular dysfunction as compared with a guideline-driven approach of withholding or
discontinuing trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1).
In SCHOLAR-2, we will compare two thresholds of withholding or discontinuing
trastuzumab/pertuzumab/trastuzumab-emtansine: a threshold that is currently advocated for by
existing treatment practice guidelines versus a more aggressive threshold that allows
trastuzumab/pertuzumab/trastuzumab-emtansine to continue at lower levels of LVEF than
currently supported by guideline documents.